FDA Approves Onyx and Bayer Colorectal Cancer Drug

NEW YORK -- The Food and Drug Administration on Thursday
approved a new colorectal cancer pill developed by Onyx
Pharmaceuticals Inc. and Bayer HealthCare.

The drug is called Stivarga, and it is designed to block several
enzymes that promote cancer growth. The FDA approved Stivarga as a
treatment for colorectal cancer that has progressed after treatment
and metastasized, or spread to other parts of the body. The agency
approved the drug about one month ahead of schedule.

In clinical studies, patients treated with Stivarga and standard
treatment had median survival of 6.4 months, compared to 5 months
for patients who were received only standard treatment.

The companies will market the drug together. Bayer developed
Stivarga, and under an agreement between the companies, Onyx will
get royalties on sales of the drug.

Stivarga, which was developed under the name regorafenib, is the
second colorectal cancer drug to win FDA approval recently. In
August the agency backed Sanofi’s drug Zaltrap as a treatment
for metastatic colon cancer in combination with chemotherapy.

The FDA says colorectal cancer is the third-most common cancer
in the U.S. and the third leading cause of cancer death. It said
around 143,460 cases are expected to be diagnosed in 2012, and
about 51,690 people will die of the disease.

Onyx and Bayer have also asked the FDA to approve Stivarga as a
treatment for gastrointestinal stromal tumors, which mostly occur
in the stomach or small intestine.

The drug is approved with a warning connected to sever and
sometimes fatal liver toxicity that was observed in some patients
in studies.

The most common side effects of Stivarga in clinical trials
included weakness or fatigue, loss of appetite, diarrhea, mouth
sores, weight loss, infection, high blood pressure, changes in
voice volume or quality, and hand-foot syndrome, a condition in
which small amounts of the drug leak out of the blood vessels in
the palms and the soles of the feet, causing reddened skin,
tenderness, and peeling.

Shares of Onyx rose 2.6 percent to $84.64 on Thursday. The stock
rose 36 cents to $85 in aftermarket trading.